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Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative |
Raw XML (canonical form + also see XML Format Specification)
Definition for Code System StateChangeReason
<?xml version="1.0" encoding="UTF-8"?> <CodeSystem xmlns="http://hl7.org/fhir"> <id value="state-change-reason"/> <meta> <lastUpdated value="2021-04-15T13:25:09.461+11:00"/> <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/> </meta> <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"> <p> This code system http://terminology.hl7.org/CodeSystem/state-change-reason defines the following codes:</p> <table class="codes"> <tr> <td style="white-space:nowrap"> <b> Code</b> </td> <td> <b> Display</b> </td> <td> <b> Definition</b> </td> </tr> <tr> <td style="white-space:nowrap">adverseEvent <a name="state-change-reason-adverseEvent"> </a> </td> <td> adverse event</td> <td> adverse event.</td> </tr> <tr> <td style="white-space:nowrap">death <a name="state-change-reason-death"> </a> </td> <td> death (adverse event)</td> <td> death (adverse event).</td> </tr> <tr> <td style="white-space:nowrap">notEligible <a name="state-change-reason-notEligible"> </a> </td> <td> did not meet eligibility criteria</td> <td> did not meet eligibility criteria.</td> </tr> <tr> <td style="white-space:nowrap">eligibleButNo <a name="state-change-reason-eligibleButNo"> </a> </td> <td> eligible but unwilling or unable to participate</td> <td> eligible but unwilling or unable to participate.</td> </tr> <tr> <td style="white-space:nowrap">enrolled <a name="state-change-reason-enrolled"> </a> </td> <td> enrolled or registered</td> <td> enrolled or registered.</td> </tr> <tr> <td style="white-space:nowrap">exclusion <a name="state-change-reason-exclusion"> </a> </td> <td> exclusion</td> <td> exclusion.</td> </tr> <tr> <td style="white-space:nowrap">followUpComplete <a name="state-change-reason-followUpComplete"> </a> </td> <td> follow-up complete</td> <td> follow-up complete.</td> </tr> <tr> <td style="white-space:nowrap">inclusion <a name="state-change-reason-inclusion"> </a> </td> <td> inclusion</td> <td> inclusion.</td> </tr> <tr> <td style="white-space:nowrap">informedConsentSigned <a name="state-change-reason-informedConsentSigned"> </a> </td> <td> Informed consent signed</td> <td> Informed consent signed.</td> </tr> <tr> <td style="white-space:nowrap">intOrObsComplete <a name="state-change-reason-intOrObsComplete"> </a> </td> <td> intervention or observation complete</td> <td> intervention or observation complete.</td> </tr> <tr> <td style="white-space:nowrap">nonCompliance <a name="state-change-reason-nonCompliance"> </a> </td> <td> non-compliance</td> <td> non-compliance.</td> </tr> <tr> <td style="white-space:nowrap">preReg <a name="state-change-reason-preReg"> </a> </td> <td> pre-registered or slot reserved</td> <td> pre-registered or slot reserved.</td> </tr> <tr> <td style="white-space:nowrap">refuseConsent <a name="state-change-reason-refuseConsent"> </a> </td> <td> refuse consent</td> <td> refuse consent.</td> </tr> <tr> <td style="white-space:nowrap">screenFailure <a name="state-change-reason-screenFailure"> </a> </td> <td> screen failure</td> <td> screen failure.</td> </tr> <tr> <td style="white-space:nowrap">studyClosed <a name="state-change-reason-studyClosed"> </a> </td> <td> study permanently closed to accrual</td> <td> study permanently closed to accrual.</td> </tr> <tr> <td style="white-space:nowrap">studyTerminated <a name="state-change-reason-studyTerminated"> </a> </td> <td> study terminated</td> <td> study terminated.</td> </tr> <tr> <td style="white-space:nowrap">subjectRefusal <a name="state-change-reason-subjectRefusal"> </a> </td> <td> subject refusal</td> <td> subject refusal.</td> </tr> <tr> <td style="white-space:nowrap">unwillingOrUnable <a name="state-change-reason-unwillingOrUnable"> </a> </td> <td> unwilling or unable to participate</td> <td> unwilling or unable to participate.</td> </tr> <tr> <td style="white-space:nowrap">withdrawnConsent <a name="state-change-reason-withdrawnConsent"> </a> </td> <td> withdrawn consent</td> <td> withdrawn consent.</td> </tr> <tr> <td style="white-space:nowrap">diseaseRelapse <a name="state-change-reason-diseaseRelapse"> </a> </td> <td> Disease Relapse</td> <td> Relapse of disease.</td> </tr> <tr> <td style="white-space:nowrap">failedRandomization <a name="state-change-reason-failedRandomization"> </a> </td> <td> Failed Randomization</td> <td> Subject failed randomization.</td> </tr> <tr> <td style="white-space:nowrap">lackOfEfficacy <a name="state-change-reason-lackOfEfficacy"> </a> </td> <td> Lack Of Efficacy</td> <td> The study activities were not efficient in dealing with the underlying issue.</td> </tr> <tr> <td style="white-space:nowrap">lostToFollowUp <a name="state-change-reason-lostToFollowUp"> </a> </td> <td> Lost To Follow Up</td> <td> The subject can no longer be followed up.</td> </tr> <tr> <td style="white-space:nowrap">physicianDecision <a name="state-change-reason-physicianDecision"> </a> </td> <td> Physician Decision</td> <td> A physician has decided the subject should no longer continue on the study.</td> </tr> <tr> <td style="white-space:nowrap">pregnancy <a name="state-change-reason-pregnancy"> </a> </td> <td> Pregnancy</td> <td> Subject is now pregnant and no longer meets the inclusion criteria.</td> </tr> <tr> <td style="white-space:nowrap">progressiveDisease <a name="state-change-reason-progressiveDisease"> </a> </td> <td> Progressive Disease</td> <td> The subject has a disease that has progressed to far to allow them to continue in the study.</td> </tr> <tr> <td style="white-space:nowrap">protocolDeviation <a name="state-change-reason-protocolDeviation"> </a> </td> <td> Protocol Deviation</td> <td> There has been a protocol deviation that cannot be corrected or compensated for.</td> </tr> <tr> <td style="white-space:nowrap">recovery <a name="state-change-reason-recovery"> </a> </td> <td> Recovery</td> <td> The subject has recovered and no longer meets the inclusion criteria.</td> </tr> <tr> <td style="white-space:nowrap">siteTerminated <a name="state-change-reason-siteTerminated"> </a> </td> <td> Site Terminated</td> <td> The site where the subject was being treated is no longer in the study.</td> </tr> <tr> <td style="white-space:nowrap">technicalProblems <a name="state-change-reason-technicalProblems"> </a> </td> <td> Technical Problems</td> <td> The subject cannot continue on the study due to technical issues.</td> </tr> <tr> <td style="white-space:nowrap">complete <a name="state-change-reason-complete"> </a> </td> <td> Complete</td> <td> The study is now complete.</td> </tr> </table> </div> </text> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"> <valueCode value="brr"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="draft"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"> <valueInteger value="1"/> </extension> <url value="http://terminology.hl7.org/CodeSystem/state-change-reason"/> <identifier> <system value="urn:ietf:rfc:3986"/> <value value="urn:oid:2.16.840.1.113883.4.642.1.1477"/> </identifier> <version value="4.6.0"/> <name value="StateChangeReason"/> <title value="StateChangeReason"/> <status value="draft"/> <experimental value="false"/> <date value="2020-12-28T16:55:11+11:00"/> <publisher value="HL7 (FHIR Project)"/> <contact> <telecom> <system value="url"/> <value value="http://hl7.org/fhir"/> </telecom> <telecom> <system value="email"/> <value value="fhir@lists.hl7.org"/> </telecom> </contact> <description value="Indicates why the state of the subject changed."/> <caseSensitive value="true"/> <valueSet value="http://hl7.org/fhir/ValueSet/state-change-reason"/> <content value="complete"/> <concept> <code value="adverseEvent"/> <display value="adverse event"/> <definition value="adverse event."/> </concept> <concept> <code value="death"/> <display value="death (adverse event)"/> <definition value="death (adverse event)."/> </concept> <concept> <code value="notEligible"/> <display value="did not meet eligibility criteria"/> <definition value="did not meet eligibility criteria."/> </concept> <concept> <code value="eligibleButNo"/> <display value="eligible but unwilling or unable to participate"/> <definition value="eligible but unwilling or unable to participate."/> </concept> <concept> <code value="enrolled"/> <display value="enrolled or registered"/> <definition value="enrolled or registered."/> </concept> <concept> <code value="exclusion"/> <display value="exclusion"/> <definition value="exclusion."/> </concept> <concept> <code value="followUpComplete"/> <display value="follow-up complete"/> <definition value="follow-up complete."/> </concept> <concept> <code value="inclusion"/> <display value="inclusion"/> <definition value="inclusion."/> </concept> <concept> <code value="informedConsentSigned"/> <display value="Informed consent signed"/> <definition value="Informed consent signed."/> </concept> <concept> <code value="intOrObsComplete"/> <display value="intervention or observation complete"/> <definition value="intervention or observation complete."/> </concept> <concept> <code value="nonCompliance"/> <display value="non-compliance"/> <definition value="non-compliance."/> </concept> <concept> <code value="preReg"/> <display value="pre-registered or slot reserved"/> <definition value="pre-registered or slot reserved."/> </concept> <concept> <code value="refuseConsent"/> <display value="refuse consent"/> <definition value="refuse consent."/> </concept> <concept> <code value="screenFailure"/> <display value="screen failure"/> <definition value="screen failure."/> </concept> <concept> <code value="studyClosed"/> <display value="study permanently closed to accrual"/> <definition value="study permanently closed to accrual."/> </concept> <concept> <code value="studyTerminated"/> <display value="study terminated"/> <definition value="study terminated."/> </concept> <concept> <code value="subjectRefusal"/> <display value="subject refusal"/> <definition value="subject refusal."/> </concept> <concept> <code value="unwillingOrUnable"/> <display value="unwilling or unable to participate"/> <definition value="unwilling or unable to participate."/> </concept> <concept> <code value="withdrawnConsent"/> <display value="withdrawn consent"/> <definition value="withdrawn consent."/> </concept> <concept> <code value="diseaseRelapse"/> <display value="Disease Relapse"/> <definition value="Relapse of disease."/> </concept> <concept> <code value="failedRandomization"/> <display value="Failed Randomization"/> <definition value="Subject failed randomization."/> </concept> <concept> <code value="lackOfEfficacy"/> <display value="Lack Of Efficacy"/> <definition value="The study activities were not efficient in dealing with the underlying issue."/> </concept> <concept> <code value="lostToFollowUp"/> <display value="Lost To Follow Up"/> <definition value="The subject can no longer be followed up."/> </concept> <concept> <code value="physicianDecision"/> <display value="Physician Decision"/> <definition value="A physician has decided the subject should no longer continue on the study."/> </concept> <concept> <code value="pregnancy"/> <display value="Pregnancy"/> <definition value="Subject is now pregnant and no longer meets the inclusion criteria."/> </concept> <concept> <code value="progressiveDisease"/> <display value="Progressive Disease"/> <definition value="The subject has a disease that has progressed to far to allow them to continue in the study."/> </concept> <concept> <code value="protocolDeviation"/> <display value="Protocol Deviation"/> <definition value="There has been a protocol deviation that cannot be corrected or compensated for."/> </concept> <concept> <code value="recovery"/> <display value="Recovery"/> <definition value="The subject has recovered and no longer meets the inclusion criteria."/> </concept> <concept> <code value="siteTerminated"/> <display value="Site Terminated"/> <definition value="The site where the subject was being treated is no longer in the study."/> </concept> <concept> <code value="technicalProblems"/> <display value="Technical Problems"/> <definition value="The subject cannot continue on the study due to technical issues."/> </concept> <concept> <code value="complete"/> <display value="Complete"/> <definition value="The study is now complete."/> </concept> </CodeSystem>
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.